FDA.reportPublic FDA data

Dr.Jart Premium Beauty Balm Light Medium-Medium

Product NDC
49404-149
11-digit product format
494040149
Labeler code
49404
Product ID
49404-149_47ed1b50-7ba6-110e-e063-6394a90a0559
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Have & Be Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-25
Substance
TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength
4.8; 5; 6.8; 4.5 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Dr.Jart Premium Beauty Balm Light Medium-Medium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE4.8 g/100mL
ZINC OXIDE5 g/100mL
OCTINOXATE6.8 g/100mL
OCTISALATE4.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
45b1c2c6-a45b-4a45-bec9-e5341079c0a1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49404-149-022024-01-30C16284748780-11030e365-6e64-111a-e063-dadaa90a10e249404-149 Dr.Jart+ Premium Beauty Balm Light Medium-Medium
49404-149-022024-01-30C16284748780-11030e365-6e64-111a-e063-dadaa90a10e249404-149 Dr.Jart+ Premium Beauty Balm Light Medium-Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49404-149-02Dr.Jart Premium Beauty Balm Light Medium-Medium1 in 1 CARTONCREAM15
49404-149-02Dr.Jart Premium Beauty Balm Light Medium-Medium40 mL in 1 BOTTLE, PUMPCREAM405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49404-149DR.JART PREMIUM BEAUTY BALM LIGHT MEDIUM-MEDIUM (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [HAVE & BE CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20241227_45b1c2c6-a45b-4a45-bec9-e5341079c0a1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 191 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c4433e2-d383-8326-e063-6294a90aaf982025-08-26WarningsExact identifier
application number: M020
Coco and Eve Sunny Honey Protect SPF 50 Coconut Milk Body SPF 50SUNSCREENSoleil Collective LLC3d4d1b94-b1ce-cf94-e063-6394a90a61ba2025-08-26WarningsExact identifier
application number: M020
naked TURTLE 30ZINC OXIDENAKED TURTLE SUNSCREEN LLC65f1570a-6156-40e6-a792-e0707607dc2f2025-08-26WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF 50ZINC OXIDEDelta Ecommerce LLC2d490531-af38-87d0-e063-6394a90acf492025-08-25WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC20d24c9d-9558-156d-e063-6294a90a2d1a2025-08-25WarningsExact identifier
application number: M020
Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF 70 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC413275e8-0011-471e-9539-ea95ed8384132025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - BananaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d34d144-2515-d7fa-e063-6294a90abb3f2025-08-25WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 sunscreenAVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 8.0%Florida Squeezed393b59aa-6d5a-4757-9f6d-59f7533aee862025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d37ec29-8d15-c716-e063-6394a90ae7092025-08-25WarningsExact identifier
application number: M020
RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN ADOREZINC OXIDERms organics LLC3d386cc9-e097-dacf-e063-6294a90a8fe22025-08-25WarningsExact identifier
application number: M020
Baby Bum Mineral 50 Mineral Sunscreen Face StickZINC OXIDESun Bum, LLC3d3a0d5c-a366-22fc-e063-6394a90a308b2025-08-25WarningsExact identifier
application number: M020
BOB Kids Sun Balm SPF 40ZINC OXIDE 23%SPF Ventures, LLCefa5c501-273c-5e97-e053-2995a90a865b2025-08-24WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCe4a2e6e4-5c35-4178-b341-65644233b7b82025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC57f91218-2477-4495-98e8-c512d823e1582025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc358745d-b9c0-4a9e-9a83-caffa04ea2e52025-08-22WarningsExact identifier
application number: M020
Neutrogena Age Shield Face Oil Free Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC050c2997-3ec0-4515-8a67-709b07a5010f2025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf3e27d-ab16-4f12-e063-6394a90a70e22025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf42e31-4e11-9b6d-e063-6294a90aa7412025-08-22WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1f619e-dd4e-ab62-e063-6294a90a10d42025-08-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49404-149-02494040149021 BOTTLE, PUMP in 1 CARTON (49404-149-02) / 40 mL in 1 BOTTLE, PUMP2022-04-250000-00-00NoNoCurrent